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NDA022304 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nucynta (Tapentadol) Tablets Are Indicated For The Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate In Adults. Nucynta Tablets Are An Opioid Analgesic Indicated For The Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. ( 1 ) Limitations Of Use ( 1 ) Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Nucynta Tablets For Use In Patients For Whom Alternative Treatment Options (E.g., Non-Opioid Analgesics Or Opioid Combination Products): Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [See Warnings And Precautions (5.1) ] , Reserve Nucynta Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Opioid Combination Products: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tapentadol Hydrochloride TAPENTADOL HYDROCHLORIDE ZINC20783

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